MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y464G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an animal underwent an unknown procedure on an unknown date and suture was used.Post-op, the entire suture site had dehisced, and it seems that the suture was degrading in 1-2 days.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 device not returned.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify how many devices were used on this single event.Was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? please provide additional details.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.T was reported that ".Following suture usages after different cases from different facility locations." please provide the specific number of patient events.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If not, please create a new pc file for every event.What is the quantity involved per event? was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? please provide additional details for each patient event.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep) for each event.If the device(s) are available for product return: please confirm the number of devices being returned for each event.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details for each event.
Additional Manufacturer Narrative
Product complaint # (b)(4), date sent to the fda: 1/27/2025, h6 component code: g07002 pending evaluation of returned devices.Additional information.A device has been received; however, clarification is requested whether the product belongs to this complaint.The following information was requested: product code z398, lot temrlz, product code z398, lot slmjta, product code z452, lot remhta, product code z452, lot uamdds, product code z451, lot tjmhhz, product code z340, lot temppq, product code z969, lot temlse, product code z304, lot sgmaua, product code y942, lot uamjdk, product code y943, lot ubmbzr.1.Please clarify if the additional devices belong to this complaint? 1a.If yes, did a device malfunction occur during the same procedure for each device? 2b.Please clarify if the device for product code y464g, lot tmmajx will be returned for evaluation? 2.If not, please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the devices were not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: MCRYL VIO 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20262441
• Report Number: 2210968-2024-10054
• Device Sequence Number: 8364457
• Product Code: GAN
• UDI-Device Identifier: 10705031059269
• UDI-Public: (01)10705031059269(17)281031(10)TMMAJX
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: Y464G
• Device Lot Number: TMMAJX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown